Excipients. USP and NF Excipients, Listed by Category. Accessed from by newp0rt1 on Thu Dec 01 21:23:02 EST NF 30 Excipients 1673

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1 NF 30 Excipients 1673 Excipients USP and NF Excipients, Listed by Category In the following reference table, the grouping of excipients by functional category is intended to summarize the most typically identified purpose that these excipients serve in drug product formulations. The list of substances included in each category is not comprehensive. The statement of category is intended neither to limit in any way the choice or use of the substance nor to indicate that it has no other utility. Acidifying Agent Acetic Acid Acetic Acid, Glacial Citric Acid, Anhydrous Citric Acid Monohydrate Fumaric Acid Hydrochloric Acid Hydrochloric Acid, Diluted Malic Acid Nitric Acid Phosphoric Acid Phosphoric Acid, Diluted Propionic Acid Sulfuric Acid Tartaric Acid Aerosol Propellant Butane Dichlorodifluoromethane Dichlorotetrafluoroethane Isobutane Propane Trichloromonofluoromethane Air Displacement Carbon Dioxide Nitrogen Alcohol Denaturant Denatonium Benzoate Methyl Isobutyl Ketone Sucrose Octaacetate Alkalizing Agent Ammonia Solution, Strong Ammonium Carbonate Diethanolamine Potassium Hydroxide Sodium Bicarbonate Sodium Borate Sodium Carbonate Sodium Hydroxide Trolamine Anticaking Agent (See Glidant) Antifoaming Agent Dimethicone Myristic Acid Palmitic Acid Simethicone Antimicrobial Preservative Benzalkonium Chloride Benzalkonium Chloride Solution Benzethonium Chloride Benzoic Acid Benzyl Alcohol Butylparaben Calcium Propionate Cetrimonium Bromide Cetylpyridinium Chloride Chlorobutanol Chlorocresol Cresol Dehydroacetic Acid Erythorbic Acid Ethylparaben Methylparaben Methylparaben Sodium Phenol Phenoxyethanol Phenylethyl Alcohol Phenylmercuric Acetate Phenylmercuric Nitrate Potassium Benzoate Potassium Sorbate Propylparaben Propylparaben Sodium Sodium Benzoate Sodium Dehydroacetate Sodium Propionate Sorbic Acid Thimerosal Thymol Antioxidant Ascorbic Acid Ascorbyl Palmitate Butylated Hydroxyanisole Butylated Hydroxytoluene Erythorbic Acid Hypophosphorous Acid Lactobionic Acid Monothioglycerol Potassium Metabisulfite Propyl Gallate Racemethionine Sodium Bisulfite Sodium Formaldehyde Sulfoxylate Sodium Metabisulfite Sodium Sulfite Sodium Thiosulfate Stannous Chloride Sulfur Dioxide Tocopherols Excipient Buffering Agent Acetic Acid Adipic Acid Ammonium Carbonate Ammonium Phosphate Boric Acid Citric Acid, Anhydrous

2 1674 Excipients NF 30 Citric Acid Monohydrate Lactic Acid Phosphoric Acid Potassium Citrate Potassium Metaphosphate Potassium Phosphate, Dibasic Potassium Phosphate, Monobasic Racemethionine Sodium Acetate Sodium Citrate Sodium Lactate Solution Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Succinic Acid Bulking Agent for Freeze-Drying Creatinine Polydextrose Capsule Lubricant (See Tablet and/or Capsule Lubricant) Chelating Agent Edetate Calcium Disodium Edetate Disodium Edetic Acid Coating Agent Amino Methacrylate Copolymer Ammonio Methacrylate Copolymer Ammonio Methacrylate Copolymer Dispersion Carboxymethylcellulose Sodium Carboxymethylcellulose Sodium, Enzymatically- Hydrolyzed Cellaburate Cellacefate (formerly Cellulose Acetate Phthalate) Cellulose Acetate Cellulose Acetate Phthalate (see Cellacefate) Coconut Oil Coconut Oil, Hydrogenated Copovidone Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion Ethylcellulose Ethylcellulose Aqueous Dispersion Ethylcellulose Dispersion Type B NF30 Ethylene Glycol and Vinyl Alcohol Graft Copolymer Gelatin Glaze, Pharmaceutical Hydroxypropyl Cellulose Hydroxypropyl Methylcellulose (see Hypromellose) Hydroxypropyl Methylcellulose Phthalate (see Hypro mellose Phthalate) Hypromellose (formerly Hydroxypropyl Methylcellulose) Hypromellose Acetate Succinate Hypromellose Phthalate (formerly Hydroxypropyl Methylcellulose Phthalate) Methacrylic Acid and Ethyl Acrylate Copolymer Methacrylic Acid and Ethyl Acrylate Copolymer, Partially-Neutralized Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion NF30 Methacrylic Acid and Methyl Methacrylate Copolymer Methacrylic Acid Copolymer Methacrylic Acid Copolymer Dispersion Methylcellulose Palm Kernel Oil Palm Oil Palm Oil, Hydrogenated Polyvinyl Acetate Polyvinyl Acetate Dispersion Polyvinyl Acetate Phthalate Rapeseed Oil, Fully Hydrogenated Rapeseed Oil, Superglycerinated Fully Hydrogenated Shellac Sucrose Titanium Dioxide Wax, Carnauba Wax, Microcrystalline Zein Color Caramel Ferric Oxide, red, yellow, or blends Coloring Agent Aluminum Oxide Complexing Agent Edetate Calcium Disodium Edetate Disodium Edetic Acid Oxyquinoline Sulfate Desiccant Calcium Chloride Calcium Sulfate Polyvinyl Acetate Silicon Dioxide Emollient Alkyl (C12-15) Benzoate Oleyl Oleate Soybean Oil, Hydrogenated Emulsifying and/or Solubilizing Agent Acacia Carbomer Copolymer Carbomer Interpolymer Cholesterol Coconut Oil Cyclodextrin, Gamma Desoxycholic Acid Diethanolamine (Adjunct) Diethylene Glycol Stearates Ethylene Glycol Stearates Glyceryl Distearate Glyceryl Monolinoleate Glyceryl Monooleate Glyceryl Monostearate Lanolin Alcohols Lecithin Mono- and Di-glycerides Monoethanolamine (Adjunct) Oleic Acid (Adjunct) Oleyl Alcohol (Stabilizer) Oleyl Oleate Palm Kernel Oil Palm Oil Poloxamer Polyglyceryl 3 Diisostearate Polyglyceryl Dioleate NF30 Polyoxyethylene 50 Stearate Polyoxyl 10 Oleyl Ether

3 NF 30 Excipients 1675 Polyoxyl 20 Cetostearyl Ether Polyoxyl 35 Castor Oil Polyoxyl 40 Hydrogenated Castor Oil Polyoxyl 40 Stearate Polyoxyl Lauryl Ether Polyoxyl Stearyl Ether Polysorbate 20 Polysorbate 40 Polysorbate 60 Polysorbate 80 Propylene Glycol Dicaprylate/Dicaprate Propylene Glycol Monocaprylate Propylene Glycol Monostearate Rapeseed Oil, Superglycerinated Fully Hydrogenated Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Sodium Stearate Sorbitan Monolaurate Sorbitan Monooleate Sorbitan Monopalmitate Sorbitan Monostearate Sorbitan Sesquioleate Sorbitan Trioleate Stannous Chloride Stearic Acid Sucrose Stearate Trolamine Wax, Emulsifying Film-Forming Agent Ammonio Methacrylate Copolymer NF30 Ethylcellulose Dispersion Type B NF30 Methacrylic Acid and Ethyl Acrylate Copolymer Methacrylic Acid and Ethyl Acrylate Copolymer, Partially- Neutralized Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion NF30 Methacrylic Acid and Methyl Methacrylate Copolymer Filtering Aid Cellulose, Powdered Siliceous Earth, Purified Flavors and Perfumes Almond Oil Anethole Benzaldehyde Ethyl Acetate Ethyl Vanillin L-Glutamic Acid, Hydrochloride Lactitol Maltol Menthol Methyl Salicylate Monosodium Glutamate Peppermint Peppermint Oil Peppermint Spirit Racemethionine Rose Oil Rose Water, Stronger Thymol Vanillin Glidant and/or Anticaking Agent Calcium Silicate Magnesium Silicate Silica, Hydrophobic Colloidal Silicon Dioxide, Colloidal Talc Humectant Erythritol Hexylene Glycol Inositol Maltitol Polydextrose Propylene Glycol Sorbitol Sorbitol Sorbitan Solution Tagatose Ointment Base Caprylocaproyl Polyoxylglycerides Diethylene Glycol Monoethyl Ether Lanolin Lauroyl Polyoxylglycerides Linoleoyl Polyoxylglycerides Ointment, Hydrophilic Ointment, White Ointment, Yellow Oleoyl Polyoxylglycerides Petrolatum Petrolatum, Hydrophilic Petrolatum, White Monomethyl Ether Polyglyceryl 3 Diisostearate Rose Water Ointment Squalane Stearoyl Polyoxylglycerides Vegetable Oil, Hydrogenated, Type II Plasticizer Acetyltributyl Citrate Acetyltriethyl Citrate Castor Oil Diacetylated Monoglycerides Dibutyl Sebacate Diethyl Phthalate Monomethyl Ether Propylene Glycol Sorbitol Sorbitan Solution Triacetin Tributyl Citrate Triethyl Citrate Polymer Membrane Amino Methacrylate Copolymer Ammonio Methacrylate Copolymer Ammonio Methacrylate Copolymer Dispersion Cellaburate Cellulose Acetate Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion Sequestering Agent Betadex (formerly Beta Cyclodextrin) Cyclodextrin, Beta (see Betadex) Cyclodextrin, Gamma Hydroxypropyl Betadex Sodium Tartrate Solvent Acetone Alcohol Alcohol, Diluted Amylene Hydrate

4 1676 Excipients NF 30 Benzyl Benzoate Carbomer Copolymer Butyl Alcohol Carbomer Homopolymer Canola Oil Carbomer Interpolymer Caprylocaproyl Polyoxylglycerides Carboxymethylcellulose Calcium Corn Oil Carboxymethylcellulose Sodium Cottonseed Oil Carboxymethylcellulose Sodium 12 Diethylene Glycol Monoethyl Ether Carboxymethylcellulose Sodium, Enzymatically- Ethyl Acetate Hydrolyzed Carmellose Hexylene Glycol Carrageenan Isopropyl Alcohol Cellulose, Microcrystalline, and Carboxymethylcellulose Lauroyl Polyoxylglycerides Sodium Linoleoyl Polyoxylglycerides Methyl Alcohol Methyl Isobutyl Ketone Methylene Chloride Dextrin Methylpyrrolidone Gelatin Mineral Oil Gellan Gum Oleoyl Polyoxylglycerides Guar Gum Peanut Oil Hydroxyethyl Cellulose Hydroxypropyl Cellulose Hydroxypropyl Methylcellulose (see Hypromellose) Monomethyl Ether Hypromellose (formerly Hydroxypropyl Methylcellulose) Propylene Glycol Sesame Oil Magnesium Aluminum Silicate Stearoyl Polyoxylglycerides Water, Purified Methylcellulose Water for Injection Pectin Water for Injection, Sterile Water for Irrigation, Sterile Polyethylene Oxide Sorbent Polyvinyl Alcohol Cellulose, Powdered Povidone Charcoal, Activated Propylene Glycol Alginate Siliceous Earth, Purified Sorbent, Carbon Dioxide Silica, Hydrophobic Colloidal Barium Hydroxide Lime Silicon Dioxide Soda Lime Silicon Dioxide, Colloidal Sodium Alginate Stiffening Agent Starch, Corn Castor Oil, Hydrogenated Starch, Hydroxypropyl Corn Cetostearyl Alcohol Starch, Hydroxypropyl Pea Cetyl Alcohol Cetyl Esters Wax Cetyl Palmitate Hard Fat Paraffin Sucrose Palmitate Paraffin, Synthetic Tragacanth Rapeseed Oil, Fully Hydrogenated Xanthan Gum Rapeseed Oil, Superglycerinated Fully Hydrogenated Stearyl Alcohol Wax, Emulsifying Wax, White Wax, Yellow Sweetening Agent Suppository Base Acesulfame Potassium Cocoa Butter Aspartame Hard Fat Aspartame Acesulfame Suspending and/or Viscosity-Increasing Agent, High Fructose Acacia Agar Dextrates Alamic Acid Dextrose Alginic Acid Dextrose Excipient Aluminum Monostearate Erythritol Attapulgite, Activated Fructose Attapulgite, Colloidal Activated Galactose Bentonite Maltitol Bentonite, Purified Bentonite Magma Carbomer 910 Saccharin Carbomer 934 Saccharin Calcium Carbomer 934P Saccharin Sodium Carbomer 940 Sorbitol Carbomer 941 Sorbitol Solution Carbomer 1342

5 NF 30 Excipients 1677 Sucralose Sucrose Sugar, Compressible Sugar, Confectioner s Syrup Tagatose Tablet Binder Acacia Alginic Acid Amino Methacrylate Copolymer Ammonio Methacrylate Copolymer Ammonio Methacrylate Copolymer Dispersion Carbomer Copolymer Carbomer Homopolymer Carbomer Interpolymer Carboxymethylcellulose Sodium Cellulose, Microcrystalline Cellulose, Silicified Microcrystalline Coconut Oil, Hydrogenated Copovidone Dextrin Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion Ethylcellulose Ethylene Glycol and Vinyl Alcohol Graft Copolymer Gelatin Glucose, Liquid Guar Gum Hydroxypropyl Cellulose, Low-Substituted Hydroxypropyl Methylcellulose (see Hypromellose) Hypromellose (formerly Hydroxypropyl Methylcellulose) Hypromellose Acetate Succinate Methylcellulose Palm Oil, Hydrogenated Polyethylene Oxide Polyvinyl Acetate Povidone Polysorbate 20 Starch, Corn Polysorbate 40 Starch, Hydroxypropyl Corn Polysorbate 60 Starch, Hydroxypropyl Pea Polysorbate 80 Starch, Pregelatinized Syrup Tablet and/or Capsule Diluent Calcium Carbonate Calcium Phosphate, Dibasic Calcium Phosphate, Tribasic Calcium Sulfate Cellulose, Microcrystalline Cellulose, Silicified Microcrystalline Cellulose, Powdered Dextrates Dextrin Dextrose Excipient Fructose Kaolin Lactitol Lactose, Anhydrous Lactose, Monohydrate Maltitol Propylene Glycol Monocaprylate Sorbitol Starch Starch, Corn Starch, Hydroxypropyl Corn Starch, Hydroxypropyl Pea Starch, Pregelatinized Sucrose Sugar, Compressible Sugar, Confectioner s Tablet and/or Capsule Lubricant Behenoyl Polyoxylglycerides Calcium Stearate Coconut Oil, Hydrogenated Glyceryl Behenate Magnesium Stearate Mineral Oil, Light Palm Oil, Hydrogenated Polyoxyl 10 Oleyl Ether Polyoxyl 15 Hydroxystearate Polyoxyl 20 Cetostearyl Ether Polyoxyl 35 Castor Oil Polyoxyl 40 Hydrogenated Castor Oil Polyoxyl 40 Stearate Sodium Lauryl Sulfate Sodium Stearyl Fumarate Sorbitan Monolaurate Sorbitan Monooleate Sorbitan Monopalmitate Sorbitan Monostearate Sorbitan Sesquioleate Sorbitan Trioleate Starch Stearic Acid Stearic Acid, Purified Sucrose Stearate Talc Vegetable Oil, Hydrogenated, Type I Zinc Stearate Tablet Disintegrant Alginic Acid Cellulose, Microcrystalline Cellulose, Silicified Microcrystalline Croscarmellose Sodium Crospovidone Hydroxypropyl Cellulose, Low-Substituted

6 1678 Excipients NF 30 Polyoxyl 15 Hydroxystearate Polacrilin Potassium Safflower Oil Sesame Oil Sodium Starch Glycolate Soybean Oil Starch Squalane Starch, Corn SOLID CARRIER Starch, Hydroxypropyl Corn Starch, Hydroxypropyl Pea Propylene Glycol Dicaprylate/Dicaprate Propylene Glycol Monocaprylate Starch, Pregelatinized Sugar Spheres STERILE ralbumin Human Sodium Chloride Injection, Bacteriostatic Water for Injection, Bacteriostatic Tonicity Agent Viscosity-Increasing Agent (See Suspending and/or Viscosity-Increasing Agent) Dextrose Water-Repelling Agent Cyclomethicone Dimethicone Potassium Chloride Simethicone Sodium Chloride Wetting and/or Solubilizing Agent Vehicle Benzalkonium Chloride Benzethonium Chloride FLAVORED AND/OR SWEETENED Cetylpyridinium Chloride Aromatic Elixir Docusate Sodium Benzaldehyde Elixir, Compound Nonoxynol 9 Octoxynol 9 Dextrose Poloxamer Ethyl Maltol Polyoxyl 10 Oleyl Ether Peppermint Water Polyoxyl 15 Hydroxystearate Sorbitol Solution Polyoxyl 20 Cetostearyl Ether Syrup Polyoxyl 35 Castor Oil Polyoxyl 40 Hydrogenated Castor Oil OLEAGINOUS Polyoxyl 40 Stearate Alkyl (C12-15) Benzoate Polysorbate 20 Almond Oil Polysorbate 40 Canola Oil Polysorbate 60 Corn Oil Polysorbate 80 Cottonseed Oil Ethyl Oleate Sodium Lauryl Sulfate Isopropyl Myristate Sorbitan Monolaurate Isopropyl Palmitate Sorbitan Monooleate Mineral Oil Sorbitan Monopalmitate Mineral Oil, Light Sorbitan Monostearate Octyldodecanol Sorbitan Sesquioleate Olive Oil Sorbitan Trioleate Peanut Oil Tyloxapol

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